Your session is about to expire
← Back to Search
Proton Beam Therapy
Adaptive Radiotherapy + Chemotherapy for Head and Neck Cancer (DARTBOARD Trial)
Phase 2
Waitlist Available
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Squamous cell carcinoma of unknown primary is not allowed.
Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
DARTBOARD Trial Summary
This trial will study whether using DART with ML setup margins can increase the rate of tumor control and/or reduce toxicity compared to using DART with standard margins.
Who is the study for?
Adults diagnosed with squamous cell carcinoma of the oropharynx, larynx, or hypopharynx (excluding some stages and types) who are in good enough health to participate. Pregnant women can't join, nor can those with distant metastasis, prior chemo for this cancer type, severe allergies to similar drugs used here, certain immune conditions including HIV, or overlapping radiation treatment areas.Check my eligibility
What is being tested?
This study tests a new radiation system called EthosTM that adapts daily based on patient anatomy changes. It's compared against standard therapy. The trial may include chemotherapy agents like cisplatin or cetuximab depending on the case. Participants will be randomly assigned to receive either adaptive radiotherapy with minimal setup margins or the current standard treatment.See study design
What are the potential side effects?
Radiation therapy side effects often include skin irritation at the treatment site, fatigue, dry mouth/throat issues if treating head and neck cancers; chemotherapy might add nausea/vomiting and increased risk of infections due to lower blood counts.
DARTBOARD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with squamous cell carcinoma in my throat, but not from an unknown primary.
Select...
My cancer is between stages I and IVB, but it's not in the early stages of glottic cancer.
Select...
I can take care of myself and am up and about more than half of the day.
Select...
My cancer can be seen or measured on scans, or I've had a small biopsy.
Select...
I am 18 years old or older.
Select...
I have not had my uterus or both ovaries removed.
DARTBOARD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Xerostomia
Secondary outcome measures
Development of acute and chronic toxicity in patients treated with and without DART
Patient reported outcomes
Risk of locoregional recurrence with and without DART
DARTBOARD Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Involved Nodal Radiotherapy with marginless Daily Adaptive Radiotherapy w or w/o chemotherapyExperimental Treatment2 Interventions
Patients in the ML/DART Arm will have their radiation plan adapted with every fraction. The adaptation process will be performed automatically on the Varian Ethos adaptive therapy software under the supervision of the treating physician.
Group II: Involved Nodal Radiotherapy with conventional margins w or w/o chemotherapyActive Control2 Interventions
If a patient loses a significant amount of weight on treatment, or the tumor contour changes substantially, repeat CT simulation and re-planning is allowed in the CM arm. However, the gross tumor volume may not be reduced due to tumor shrinkage. The original extent of disease must be included in the replanned GTV.
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,055 Previous Clinical Trials
1,054,819 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had chemotherapy for this cancer before, but treatment for another cancer is okay.I agree to use effective birth control during and for 90 days after the study.My cancer is in the early stages and located in my vocal cords.I have cancer in areas other than the oropharynx, larynx, and hypopharynx, except for low-risk prostate or well-differentiated thyroid cancer.I had cancer before, but it's expected to stay away for less than 3 years.I do not have any severe illnesses that would stop me from following the study's requirements.I have a history of severe immune system problems, including HIV, or have had a transplant.I have been diagnosed with squamous cell carcinoma in my throat, but not from an unknown primary.My cancer is between stages I and IVB, but it's not in the early stages of glottic cancer.I have had radiation in the same area as my current cancer.I am a woman capable of becoming pregnant.I can take care of myself and am up and about more than half of the day.My cancer can be seen or measured on scans, or I've had a small biopsy.All of my cancer and affected lymph nodes have been surgically removed.I may have surgery through the mouth for early-stage cancer in my tonsil or base of tongue.My cancer has spread to distant parts of my body.You have had allergic reactions to similar medications or treatments that are similar to the chemotherapy drugs used in this study.I am 18 years old or older.I have not had my uterus or both ovaries removed.
Research Study Groups:
This trial has the following groups:- Group 1: Involved Nodal Radiotherapy with marginless Daily Adaptive Radiotherapy w or w/o chemotherapy
- Group 2: Involved Nodal Radiotherapy with conventional margins w or w/o chemotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger